NCT04362007 · REGISTRY CONDITION SEARCH

A Phase I/II Study of ASTX660 in Patients With Relapsed or Refractory T-cell Lymphoma

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE1, PHASE2
Status at capture: TERMINATED
Registry last update: 2026-02-25

Phase 1 (dose-escalation part): Investigate the tolerability and safety of ASTX660 in patients with r/r PTCL and r/r CTCL and determine the recommended dose (RD) for the Phase 2. Phase 1 (ATLL expansion part): Evaluate the safety of ASTX660 at RD in patients with r/r ATLL. Phase 2 : Evaluate the efficacy of ASTX660 at RD in patients with r/r PTCL.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Safety (Phase 1 Dose-escalation Part) - Number of Subjects With Dose-limiting Toxicities (DLTs), AEs, Abnormal Clinical Laboratory Values or Physical Exam Results

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outcome · POSTED

Pharmacokinetic Outcome of Concentration-time Curve (AUC)

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outcome · POSTED

Pharmacokinetic Outcome of Maximum Concentration (Cmax)

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outcome · POSTED

Pharmacokinetic Outcome of Time to Maximum Concentration (Tmax)

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outcome · POSTED

Pharmacokinetic Outcome of Elimination Half Life (t½)

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outcome · POSTED

Pharmacokinetic Outcome of Clearance of Drug From Plasma

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: 1. Patients with T-cell lymphoma with histological diagnosis based on WHO classification (2017) 2. Patients with evaluable lesions. 3. Patients with ECOG PS score of 0 or 1. 4. Patients with adequate organ functions as shown below. * AST and ALT ≤ 2.0 × ULN (≤ 3.0 × ULN if liver infiltration is present) * Total bilirubin ≤ 1.5 × ULN * ANC ≥ 1,000/mm3 (≥ 750/mm3 if bone marrow infiltration is present) * Platelet count 50,000/mm3 (25,000/mm3 if bone marrow infiltration is present) * Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL/min * Amylase and lipase ≤ 1.0 × ULN Exclusion Criteria: 1. Patients with active infection requiring treatment with antibiotics, antifungals, or antivirals 2. Patients with heart disease that meets the followings: 1. LVEF of \< 50% by echocardiography or MUGA scan 2. Congestive heart failure (NYHA classification III or IV) 3. Uncontrolled heart disease including unstable angina pectoris or hypertension considered to require hospitalization within last 3 months (90 days) 4. Complete left bundle branch block, III degree (complete) atrioventricular block, use of pacemaker, history or complication of poorly controlled arrhythmia requiring treatment 5. History or complication of long QT syndrome 6. History or complication of ventricular arrhythmia requiring active treatment 7. Corrected QT interval of ≥ 470 msec based on 12-lead ECG performed at the screening 8. Concern on increased cardiac risk by participating in the study based on medical judgment 3. Patients receiving the following treatment for the primary disease prior to the initial dose of study drug 1. Chemotherapy or radiotherapy within last 3 weeks 2. Skin directed therapy including local treatment or phototherapy within last 3 weeks 3. Treatment with monoclonal antibody within last 4 weeks 4. Treatment with other study drugs or study treatment within last 3 weeks or 5 half-lives, whichever is longer 4. Patients with prior allogeneic stem cell transplantation, or autologous stem cell transplantation within 14 weeks prior to the day of initial dose of study drug 5. Patients who have received corticosteroids at a dose exceeding a prednisone equivalent dose of 10 mg/day within 3 weeks prior to the initial dose of study drug. 6. Patients with Inadequately controlled diabetes mellitus
healthy Volunteers: false
minimum Age: 20 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Subjects with r/r PTCL and r/r CTCL will receive ASTX660 once a day for 7 consecutive days every other week of each 28-day cycle (ie, \[7 days on/ 7 days off\] ×2; daily dosing on Days 1-7 and 15-21). The starting dose will be escalated stepwise in successive cohorts of 3 to 6 evaluable subjects each (standard 3+3 study design), until the RD is determined.
intervention Names
Drug: ASTX660
label
Phase 1 dose-escalation part
type
EXPERIMENTAL
description
Subjects with r/r ATLL will receive ASTX660 at RD obtained from the Phase 1 part (dose-escalation part) once a day for 7 consecutive days every other week of each 28-day cycle.
intervention Names
Drug: ASTX660
label
Phase 1 ATLL expansion part
type
EXPERIMENTAL
description
Subjects with r/r PTCL will receive ASTX660 at RD obtained from the Phase 1 part (dose-escalation part) once a day for 7 consecutive days every other week of each 28-day cycle.
intervention Names
Drug: ASTX660
label
Phase 2
type
EXPERIMENTAL

interventions

arm Group Labels
Phase 1 dose-escalation part
description
Treatment of ASTX660 for r/r PTCL and r/r CTCL
name
ASTX660
type
DRUG
arm Group Labels
Phase 1 ATLL expansion part
description
Treatment of ASTX660 for r/r ATLL
name
ASTX660
type
DRUG
arm Group Labels
Phase 2
description
Treatment of ASTX660 for r/r PTCL
name
ASTX660
type
DRUG

Study design

allocation

NON_RANDOMIZED

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 8
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Dose-limiting toxicities were defined as AEs occurring during this period that meet any of the following criteria, were not related to the primary disease, complication(s), or concomitant medication(s), and has a reasonable relationship with ASTX660. The Common Terminology Criteria for Adverse Events Version 4.03 (CTCAE v4.03) was used to determine severity. 1. Grade 4 thrombocytopenia, Grade 3 or higher clinically significant bleeding, or anemia requiring a new erythrocyte transfusion 2. Febrile neutropenia that does not resolve within 3 days or Grade 4 neutropenia that lasts for more than 7 days under appropriate treatment 3. Liver-associated abnormalities 4. Excepting the above AEs, any other Grade 3 or higher nonhematologic or Grade 4 hematologic toxicity except Grade 3 nausea, vomiting, or diarrhea lasting less than 48 hours
measure
Safety (Phase 1 Dose-escalation Part) - Number of Subjects With Dose-limiting Toxicities (DLTs), AEs, Abnormal Clinical Laboratory Values or Physical Exam Results
time Frame
28 days (Day1 to Day29)

secondary Outcomes

description
Assessment of pharmacokinetic parameter area under the concentration-time curve (AUC).
measure
Pharmacokinetic Outcome of Concentration-time Curve (AUC)
time Frame
Day1: pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 24hours post-dose, Day7: pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 24, 48, 72 hours post-dose
description
Assessment of pharmacokinetic parameter maximum concentration (Cmax).
measure
Pharmacokinetic Outcome of Maximum Concentration (Cmax)
time Frame
Day1: pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 24hours post-dose, Day7: pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 24, 48, 72 hours post-dose
description
Assessment of pharmacokinetic parameter time to maximum concentration (Tmax).
measure
Pharmacokinetic Outcome of Time to Maximum Concentration (Tmax)
time Frame
Day1: pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 24hours post-dose, Day7: pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 24, 48, 72 hours post-dose
description
Assessment of pharmacokinetic parameter elimination half life (t½).
measure
Pharmacokinetic Outcome of Elimination Half Life (t½)
time Frame
Day1: pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 24hours post-dose, Day7: pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 24, 48, 72 hours post-dose
description
Assessment of pharmacokinetic parameter clearance of drug from plasma.
measure
Pharmacokinetic Outcome of Clearance of Drug From Plasma
time Frame
Day1: pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 24hours post-dose, Day7: pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 24, 48, 72 hours post-dose

Full study description

brief Summary: Phase 1 (dose-escalation part): Investigate the tolerability and safety of ASTX660 in patients with r/r PTCL and r/r CTCL and determine the recommended dose (RD) for the Phase 2. Phase 1 (ATLL expansion part): Evaluate the safety of ASTX660 at RD in patients with r/r ATLL. Phase 2 : Evaluate the efficacy of ASTX660 at RD in patients with r/r PTCL.

Source references

Source notices and limitations

Discovery and provenance

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exact text
NCT04362007
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source url
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Preserved source evidence · Not medical advice